Expert Interview: Analyzing Biomarkers in Drug Development
Biomarkers as indicators of biological and pathogenic processes have been used for decades to diagnose patients and prescribe treatment. In the past 10 years, however, they’ve substantially changed drug development practices. The demand for analyzing biomarkers in drug development has increased dramatically with the advancement of precision medicine. In the drug development context, biomarkers that are indicative of mechanism of action, target engagement, and clinical outcomes have been employed to assess both the safety and efficacy of an intervention. More specifically, biomarkers have been used either to select patients for clinical trials, to make go/no-go decisions, to support registration and label claims, or to treat patients.
Fact Sheet: Bioanalytical Large Molecule
Gain access to comprehensive biologics services in support of advanced development programs with Frontage’s bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation.
Fact Sheet: Bioanalytical Biomarkers
Frontage’s Bioanalytical Team is highly experienced in developing, qualifying and validating Biomarker assays. We have expertise in ELISA, ECL based platforms as well as ultra-sensitive detection capabilities (Quanterix SimoaTM) for quantitation in the femtogram/mL range including single and multiplex analysis in various disease categories (e.g. Inflammation, Oncology, Neuroscience, Infectious Diseases, Respiratory, etc.).
Brochure: Frontage Laboratories Company Overview
Frontage Laboratories, Inc. is a CRO providing integrated, scientifically-driven research, analytical and development services. With over 17 years of experience, we have successfully assisted our clients in advancing hundreds of compounds through the drug development process.
Poster: ADC PK Profiling Strategies on LC-MS Platforms: Top-down, Bottom-up…
With more monoclonal antibody (mAb) drug conjugates (ADC’s) under preclinical development and in clinical studies, comprehensive and reliable pharmacokinetic evaluation of ADC moieties is increasingly demanded. Liquid chromatography coupled to mass spectrometry (LC-MS) methods have served as sensitive, selective, and versatile tools for ADC PK profiling. Presented here are ADC LC-MS methodology approaches used at Frontage.